Development and Validation of Stability Indicating Assay Method By HPLC for Estimation Of Benzonatate
Main Article Content
Quality, purity, safety and efficacy of pharmaceuticals are important issues in drug therapy.A greater emphasis is being paid today on assurance of the quality and safety of a drug by monitoring and controlling the impurities and degradation products. The control of impurities and degradation products in dosage form became mandatory critical issue since their presence extensively diminishes both quality and safety of Active Pharmaceutical ingredient (API) and its dosage form. By the identification or characterization and quantification of the impurities and related substances, the risk of their impact on drug and its dosage form can be avoided or minimized. Various regulatory authorities like ICH, USFDA, Canadian Drug and Health agency are even emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). A stability indicating hyphenated analytical techniques has been developed and validated for Benzonatate as per International Conference on Harmonization.The Benzonatate standard was exposed to acid hydrolysis, alkali hydrolysis , oxidation , photolytic and thermolytic degradation condition and separated using Column HiQSil C18 (250 ´4.6mm,5µ) Mobile Phase is Methanol (0.01%), Formic Acid (70:30v/v), Flow rate 1ml/min Column Temperature is Ambient Detector set at 308nm RT (min): 4.220 ± 0.787 Asymmetry: 1.12 Plates (N): 4136. This method was validated for linearity, precision, accuracy, ruggedness and robustness. Results obtained after validation study indicating that the proposed single method allowed analysis of degraded product formed of Benzonatateformed under the various stress conditions.
"Benzonatate Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Retrieved 23 March 2019.
Becker, DE (2010). "Nausea, vomiting, and hiccups: a review of mechanisms and treatment". Anesthesia Progress. 57 (4): 150–6.
"Drugs for cough". The Medical Letter on Drugs and Therapeutics. 60 (1562): 206–208. 17 December 2018.
"Tessalon - benzonatate capsule". DailyMed. 20 November 2019. Retrieved 21 April 2020.
"Benzonatate Use During Pregnancy". Drugs.com. 10 October 2019. Retrieved 20 February 2020.
Homsi, J.; Walsh, D.; Nelson, K. A. (November 2001). "Important drugs for cough in advanced cancer". Supportive Care in Cancer. 9 (8): 565–574.
Bishop-Freeman SC, Shonsey EM, Friederich LW, Beuhler MC, Winecker RE (June 2017). "Benzonatate Toxicity: Nothing to Cough At". J Anal Toxicol. 41 (5): 461–463.
Patel A. B, “Analytical Method Validation: Collation between International Guidelines, Asian Journal of Research in Chemistry”, 2017; 10(6):1-10.
ICH Harmonized Tripartite Guideline, ICH Q2 (R1); Text & Methodology; November 2007, pp 6.